NCT01725672 - Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 27, 2012

Primary Completion Date

August 21, 2013

Study Completion Date

August 21, 2013

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG

Metformin, 500 mg extended release tablet

In Part A and Part B of the study, Metformin 500 mg XR tablet will be administered with 240 millilitre (mL) water ; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Metformin, 1000 mg extended release tablet

In Part A and Part B of the study, Metformin 1000 mg XR tablet will be administered with 240mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Glimepiride, 1 mg immediate release tablet

In Part A and Part B of the study, Glimepiride 1 mg IR tablet will be administered with 240mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Glimepiride, 2 mg immediate release tablet

In Part A and Part B of the study, Glimepiride 2 mg IR tablet will be administered with 240mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Metformin, 500 mg and Glimepiride, 1 mg extended release film coated tablet containing release controlling polymers

In Part A of the study, 1 XR film coated tablet combination of Metformin 500 mg and Glimepiride 1 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Metformin, 1000 mg and Glimepiride, 2 mg extended release film coated tablet containing release controlling polymers

In Part A of the study, 1 XR film coated tablet combination of Metformin 1000 mg and Glimepiride 2 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Metformin, 500 mg and Glimepiride, 1 mg extended release tablet coated with release controlling polymers

In Part B of the study, 1 XR tablet combination of Metformin 500 mg and Glimepiride 1 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

DRUG

Metformin, 1000 mg and Glimepiride, 2 mg extended release tablet coated with release controlling polymers

In Part B of the study, 1 XR tablet combination of Metformin 1000 mg and Glimepiride 2 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.

Trial Locations (1)

2031

GSK Investigational Site, Randwick